Crohn's Disease (CD) · Rheumatoid Arthritis (RA) · Ulcerative Colitis (UC)
Ketogenic or Carnivore Diets for Adults With IBD or Rheumatoid Arthritis
This randomized study is investigating how ketogenic and carnivore diets affect quality of life, symptoms, inflammation, nutritional status, and cardiometabolic health in adults with inflammatory bowel disease or rheumatoid arthritis.
Registry title: Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–64 Years
- Treatment
- Ketogenic diet or Carnivore (Lion) Diet
- Design
- Randomized
- Central study contact
- Robert D Abbott, MD4342183425info@resilientrootsfxevomed.com
- Sponsor
- Fuller Research Foundation
Research question
Do ketogenic or carnivore dietary programs change quality of life, disease-related symptoms, inflammatory markers, nutritional status, or cardiometabolic measures in adults with inflammatory bowel disease or rheumatoid arthritis?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 to 64.
- Participants must have a medically verifiable diagnosis of Crohn's disease, ulcerative colitis, or rheumatoid arthritis.
- Participants must currently live in the continental United States.
- Participants must be willing and able to follow the assigned dietary protocol and complete a three-week run-in period.
Participation overview
What participation may involve
Participation lasts approximately 27 weeks: a three-week baseline run-in followed by two 12-week phases. Participants complete dietary activities, questionnaires, home measurements, and laboratory testing; wait-list participants begin a dietary program after week 12. What participation may involve: - Follow an assigned ketogenic or carnivore dietary program, or continue the baseline diet during the initial 12-week wait-list period. - Receive dietary education, sample meal plans, scheduled group telehealth support, monitoring, and messaging access to medical and nutrition staff while in a dietary group. - Complete quality-of-life, symptom, psychometric, dietary-adherence, progress, and satisfaction questionnaires at specified study intervals. - Complete blood testing, at-home stool collection, finger-stick glucose and ketone measurements, dietary journals, and body-composition measurements. - At week 12, participants originally assigned to a dietary group may continue that diet or voluntarily cross over to the other diet with clinical-team approval. Total participation is approximately 27 weeks, including a three-week baseline run-in and a 24-week intervention period divided into two 12-week phases.
Study interventions
What participants may receive or do
- Ketogenic diet: Participants assigned to this dietary program receive virtual guidance for a high-fat, moderate-protein, very-low-carbohydrate diet, including food guides, sample meal plans, group telehealth sessions, and messaging with the clinical team.
- Carnivore (Lion) Diet: Participants assigned to this dietary program receive virtual guidance for a restrictive diet described as ruminant meat, salt, and water, with guidance also addressing a broader carnivore diet; support includes food guides, sample meal plans, telehealth sessions, and clinical-team messaging.
Study design
How the comparison works
This is an open-label randomized study with ketogenic-diet, carnivore-diet, and wait-list groups. The wait-list group continues its baseline diet for 12 weeks before a second randomization to one of the dietary programs. The first randomization assigns participants equally across ketogenic diet, carnivore diet, and wait-list groups while stratifying by inflammatory bowel disease or rheumatoid arthritis. At 12 weeks, wait-list participants are randomized to one of the two diets. The registry reports no masking, meaning participants and study staff are not blinded to group assignment. The initial control is a 12-week wait list whose participants continue their baseline dietary pattern without study dietary guidance while completing similar questionnaires and laboratory testing.
Reported activities
Procedures and tests
- Quality-of-life assessment using the 36-Item Short Form Health Survey (SF-36).
- Disease-specific symptom questionnaires for rheumatoid arthritis or inflammatory bowel disease, depending on the participant's condition.
- Fasted blood collection for immune and inflammatory markers, nutritional status, and cardiometabolic measures.
- At-home stool collection, including fecal calprotectin measurement for participants with inflammatory bowel disease.
- Periodic at-home finger-stick blood ketone and blood glucose measurements using provided meters.
- Periodic body-composition measurements using a provided bioelectrical-impedance scale, including weight, body mass index, skeletal muscle mass, body-fat percentage, and estimated visceral fat.
- Historical food-frequency questionnaire plus qualitative and quantitative records of dietary intake.
- Dietary adherence, progress, and satisfaction questionnaires during the study.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- A medically verifiable diagnosis of inflammatory bowel disease or rheumatoid arthritis is required.
- Participants must currently live in the continental United States.
- Participants must be willing and able to follow the study's dietary protocols.
Possible reasons someone may not be able to join
- People younger than 18 or older than 64, or outside the study's body mass index criteria, are excluded; the registry does not state the body mass index range.
- People with type 1 or type 2 diabetes who use prescription medications, including insulin, are excluded.
- For inflammatory bowel disease, a history of strictures or fistulas is exclusionary.
- Starting a disease-modifying or biologic medication within the previous two months is exclusionary.
- Pregnant people, people within six months after delivery, and people who are breastfeeding are excluded.
- People with heart, liver, or kidney failure or disease, or another type of organ failure, are excluded.
- A malignancy within the year before enrollment is exclusionary.
- A red-meat allergy or alpha-gal allergy is exclusionary.
- People unable to complete the initial three-week run-in period are excluded.
- People who do not speak English are excluded.
Important unknowns
What the record does not make clear
- The record mentions scheduled group telehealth sessions, monitoring, questionnaires, and testing at several intervals but does not give a complete visit calendar or session frequency.
- The record does not clearly explain which existing inflammatory bowel disease or rheumatoid arthritis treatments may continue during the study.
- Participants must discontinue supplements started within one month of enrollment, but the timing and scope of medication or supplement washout requirements are not fully described.
- The record does not describe what treatment is available if inflammatory bowel disease or rheumatoid arthritis worsens during the study.
- The record describes stool and blood testing but does not state whether endoscopy is required.
- The record does not explain which study-related tests, equipment, dietary foods, or clinical services are paid for.
- The record does not state whether participants receive compensation.
- The record does not state whether travel reimbursement or other travel support is available.
- Dietary guidance and support are described as virtual, but the record does not clearly state whether all activities can be completed remotely or where laboratory collections occur.
- The registry excludes people outside the study's body mass index criteria but does not report the accepted range.
- The arm named for ketogenic diet after the wait list describes carnivore-diet counseling even though its linked intervention is ketogenic diet.
Before contacting the site
Questions for the study team
- What is the complete schedule for telehealth sessions, questionnaires, laboratory visits, stool collections, and home measurements?
- Can all study activities be completed remotely, and where would blood and stool samples be collected or submitted?
- Which current inflammatory bowel disease or rheumatoid arthritis medications may continue during the trial?
- What happens if symptoms, laboratory markers, or disease activity worsen during the study?
- What body mass index range is required?
- Which study-related tests, equipment, foods, and clinical services are covered, and is compensation or travel support available?
- Is an endoscopy required for screening or follow-up?
- Does the ketogenic-after-wait-list group receive ketogenic or carnivore dietary counseling?
Before changing care
Questions for your gastroenterologist
- How stable is my inflammatory bowel disease now, and what signs would make a restrictive dietary study medically concerning in my situation?
- Could my current inflammatory bowel disease medications continue without interruption, and what risks would treatment changes create?
- What approved treatment or nutrition alternatives should I compare with this study before deciding whether to contact the research team?
- How should disease activity be monitored beyond symptoms if I explore participation?
- How should you and the research team coordinate if my symptoms worsen or my laboratory results change?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
This study is a randomized controlled clinical trial evaluating whether two therapeutic dietary approaches - a ketogenic diet and a carnivore (lion) diet - can improve quality of life, reduce symptoms, and influence measures of disease activity in adults with inflammatory bowel disease \[ulcerative colitis and Crohn's disease\] (IBD) or rheumatoid arthritis (RA). Participants will be randomized into one of three groups: 1) Ketogenic Diet, 2) Carnivore (Lion) Diet or 3) Wait-List Control. Participants randomized to a dietary group (ketogenic diet or carnivore diet) will be provided guidance on their specific dietary therapy and answer questions about their symptoms and quality of life at different intervals over a 24 week period. Participants will also complete laboratory testing at different intervals to assess for changes in nutritional status, cardiometabolic health and markers of immune activation and inflammation. Participants initially placed on the wait-list group will be asked similar questions about their symptoms and quality of life and complete the same laboratory testing as participants in a dietary group. Participants on the wait list will then be compared to participants following a specific dietary pattern to assess for any differences between the 2 groups. After 12 weeks, participants on the wait list will be randomized to a dietary group (ketogenic diet or carnivore diet) and followed in a similar fashion for an additional 12 week period.
The primary goal of this study is to determine whether ketogenic or carnivore dietary therapy improves, health-related quality of life, disease specific symptom burden or objective inflammatory markers in patients with a history of IBD or RA. Given the limited prospective data on carnivore (lion) diet approaches for addressing autoimmune conditions, the study aims to assess feasibility of implementation as well as overall safety including the documentation of common adverse events, changes to nutritional status or changes to cardiometabolic status including blood lipids. Total participation time is approximately 27 weeks including a 3-week baseline run-in and a 24-week dietary intervention period divided into 2, 12-week phases. Randomization and 3 week run-in period Participants will be randomized in a 2-2-2 schema, stratified by disease state (IBD or RA), to the carnivore (lion) diet, ketogenic diet, or placed on a wait-list. Participants will receive an at-home blood ketone and blood glucose monitoring device and a digital body composition scale. Participants will discontinue any supplements started within one month of study enrollment. Participants will then complete questionnaires and laboratory testing across several areas to include: Baseline quality-of-life, psychometric, and disease-specific symptom questionnaires Baseline body composition assessment and a historical food frequency questionnaire Baseline qualitative and quantitative analysis of self reported dietary intake Baseline at-home finger-stick blood ketone and blood glucose monitoring Baseline fasted blood collection and at-home stool collection Initial dietary intervention and support Participants randomized into a dietary intervention group will receive educational materials, including recommended foods and structured meal plans, with ongoing virtual access to medical and nutrition providers. Participants will join scheduled group telehealth sessions tailored to their dietary intervention to review study procedures, ask questions, and receive support within a community of fellow participants. Participants will receive ongoing telehealth monitoring from the medical and nutritional staff. Participants will complete certain study questionnaires around dietary adherence, progress and satisfaction at different intervals throughout the study. Participants will also also complete qualitative and quantitative dietary journals alongside at home blood ketone and blood glucose at various intervals throughout the study. Midpoint questionnaires and testing After the first 12 weeks of their specified dietary intervention, participants will complete questionnaires and testing similar to their baseline to assess for any initial changes. Participants initially placed on the wait-list will be asked similar questions about their symptoms and quality of life and complete the same laboratory testing as participants in a dietary group for the purposes of comparison at 12 weeks. Following the completion of their midpoint testing, participants on the wait list will be randomized to a dietary group (ketogenic diet or carnivore diet) and complete the same initial 12 week dietary program as those originally randomized to a dietary group. Individuals in the original dietary groups will continue for an additional 12 weeks in their specified dietary interventions OR voluntarily elect to "cross-over" into the other dietary intervention arm with the approval of the clinical team. Participants in either dietary intervention group will continue to receive ongoing support, education and virtual access to the medical and nutritional team. Final Questionnaires and Testing After 24 weeks (2, 12 week dietary phases), all study participants will repeat baseline study questionnaires and laboratory testing for the sake of comparison of key outcome measures at 24 weeks.
Study design and administration
- Organization
- Fuller Research Foundation
- Organization class
- Other
- Organization study ID
- BB2506RA-104
- Lead sponsor
- Fuller Research Foundation
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult
Study arms
Experimental
Ketogenic Diet 24 Weeks
Participants with IBD or RA randomized initially to receive dietary counseling regarding the ketogenic diet for up to 24 weeks
Interventions: Behavioral: Ketogenic diet
Experimental
Carnivore (Lion) Diet 24 Weeks
Participants with IBD or RA randomized initially to receive dietary counseling regarding the carnivore (lion) diet for up to 24 weeks
Interventions: Behavioral: Carnivore (Lion) Diet
No Intervention
Wait List 12 Weeks
Participants with IBD or RA randomized initially to a 12 week waitlist who will continue their baseline dietary pattern WITHOUT specific dietary guidance/intervention
Experimental
Carnivore (Lion) Diet for 12 weeks AFTER Wait-List
Participants with IBD or RA randomized initially to the wait-list for 12 weeks who are then randomized to receive dietary counseling regarding the carnivore (lion) diet for a subsequent 12 weeks
Interventions: Behavioral: Carnivore (Lion) Diet
Experimental
Ketogenic Diet for 12 Weeks AFTER Wait-List
Participants with IBD or RA randomized initially to the wait-list for 12 weeks who are then randomized to receive dietary counseling regarding the carnivore (lion) diet for a subsequent 12 weeks
Interventions: Behavioral: Ketogenic diet
Experimental
Voluntary Crossover - Ketogenic Diet to Carnivore (Lion) Diet AFTER 12 weeks
Participants with IBD or RA randomized initially to the ketogenic diet for 12 weeks who voluntarily choose to crossover to the carnivore (lion) diet intervention for the final 12 weeks
Interventions: Behavioral: Ketogenic diet, Behavioral: Carnivore (Lion) Diet
Experimental
Voluntary Crossover - Carnivore (Lion) Diet to Ketogenic Diet AFTER 12 weeks
Participants with IBD or RA randomized initially to the carnivore (lion) diet for 12 weeks who voluntarily choose to crossover to the ketogenic diet intervention for the final 12 weeks
Interventions: Behavioral: Ketogenic diet, Behavioral: Carnivore (Lion) Diet
Interventions
Behavioral
Ketogenic diet
The ketogenic diet is a high fat, moderate protein, and very low carbohydrate nutritional approach designed to shift the body's primary energy source from glucose to ketones, compounds produced in the liver from fat metabolism. This state of nutritional ketosis typically occurs when carbohydrate intake is restricted to 20-50 grams per day, though the exact threshold varies based on individual factors such as muscle mass, insulin sensitivity, and physical activity. Participants will receive nutritional guidance for the ketogenic diet in a virtual setting via both synchronous and asynchronous engagement including group telehealth sessions, dietary education guides/food lists, quantitative sample meals plans and ongoing messaging capacity with the clinical team for the duration of the dietary intervention.
Behavioral
Carnivore (Lion) Diet
The carnivore (lion) diet is a more restrictive form of a ketogenic diet that is intended as an elimination dietary protocol composed exclusively of ruminant meats (beef, lamb, bison, venison, goat, moose, elk), salt, and water. A broader carnivore diet includes more animal foods such as additional meats, fish, eggs, and some dairy. It excludes, however, all plant foods including vegetables, fruits, grains, legumes, nuts, seeds, or plant-derived oils. Participants will receive nutritional guidance for the carnivore (lion) and the broader carnivore diet in a virtual setting via both synchronous and asynchronous engagement including group telehealth sessions, dietary education guides/food lists, quantitative sample meals plans and ongoing messaging capacity with the clinical team for the duration of the dietary intervention.
Eligibility
18 Years–64 Years
All
Not accepted
Inclusion criteria (3)
- Diagnosed with medically verifiable IBD or medically verifiable RARegistry-derived · unreviewed
- Current personal residence in the continental U.S.Registry-derived · unreviewed
- Willingness and ability to follow dietary protocolsRegistry-derived · unreviewed
Exclusion criteria (16)
- Inability to provide consentRegistry-derived · unreviewed
- Individuals with Type 1 or Type II Diabetes on prescription medications including insulinRegistry-derived · unreviewed
- Outside of the age or BMI criteriaRegistry-derived · unreviewed
- No medically definitive or verifiable diagnosis of IBD or RARegistry-derived · unreviewed
- History of strictures or fistula (IBD)Registry-derived · unreviewed
- History of blood transfusion in the previous 6 monthsRegistry-derived · unreviewed
- PregnancyRegistry-derived · unreviewed
- 6 months PostpartumRegistry-derived · unreviewed
- BreastfeedingRegistry-derived · unreviewed
- On other medications outside of FDA approved medicationsRegistry-derived · unreviewed
- Current initiation of disease modifying or biologic medication within the past 2 monthsRegistry-derived · unreviewed
- Unable to complete, for any reason, the initial 3-week run-in period prior to the beginning of the formal study interventionRegistry-derived · unreviewed
- Non-English SpeakingRegistry-derived · unreviewed
- Organ failure of any kind including heart, liver and kidney failure or diseaseRegistry-derived · unreviewed
- History of malignancy within the last year prior to enrollmentRegistry-derived · unreviewed
- Red meat allergy, alpha-gal allergyRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36)
Time frame: From baseline to 24 weeks
The SF-36 consists of 8 subscales including: physical functioning, role limitations due to physical health (physical role functioning), role limitations due to emotional problems (emotional role functioning), vitality, mental health, social role functioning, bodily pain and general health. Scores for each subscale will be on a 0-100 scale with higher scores generally reflecting better health or less functional impairment for that respective subscale.
Primary outcome
Change in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36)
Time frame: From baseline to 12 weeks
The SF-36 consists of 8 subscales including: physical functioning, role limitations due to physical health (physical role functioning), role limitations due to emotional problems (emotional role functioning), vitality, mental health, social role functioning, bodily pain and general health. Scores for each subscale will be on a 0-100 scale with higher scores generally reflecting better health or less functional impairment for that respective subscale.
Secondary outcome
Change in Rheumatoid Arthritis Disease Activity Index-5 Questionnaire (RADAI-5)
Time frame: From baseline to 12 and 24 weeks
RADAI-5 is a 5-item questionnaire designed to assess rheumatoid arthritis symptomatic activity. Scores for each item are on a 0-10 scale. Higher scores indicate worse outcome/symptoms. \*\*RA only\*\*
Secondary outcome
Change in Routine Assessment of Patient Index Data (RAPID-3)
Time frame: From baseline to 12 and 24 weeks
RAPID-3 is a questionnaire used to monitor rheumatoid arthritis symptoms and disease activity by measuring a participant's functional status, pain, and overall perception of health. Scores range from 0-30; higher scores indicate worse outcome." \*\*RA only\*\*
Secondary outcome
Change in Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI-SF)
Time frame: From baseline to 12 and 24 weeks
The IBDSI-SF measures the frequency and severity of IBD related symptoms as well as their interference with overall functioning and daily activities. We are using a version with 23 questions that excludes the bowel complications subscale - questions 24 and 25 related to fistulas given this as an exclusion criteria. 22 of the 23 questions are scored on a 0-4 scale with higher scores reflecting worse outcome/symptoms. 1 question is rated on a 0-2 scale with a higher score reflecting a worse outcome/symptom. Total scores range from 0-90, higher scores indicating worse outcomes. \*\*IBD only\*\*
Secondary outcome
Change in fecal calprotectin
Time frame: From baseline to 12 and 24 weeks
Fecal calprotectin is a well established biomarker for intestinal inflammation and validated for diagnosis and monitoring of disease activity in patients with IBD. \*\*IBD only\*\*
Secondary outcome
Change in immune and inflammatory serology
Time frame: From baseline to 12 and 24 weeks
Participants will have associated immune and inflammatory serology to include: 1. Total white blood cell count (WBC), 2. Immune cell differential \[neutrophils, lymphocytes, monocytes, eosinophils, and basophils\] 3. High sensitivity C-reactive protein (hs-CRP), 4. Erythrocyte sedimentation rate (ESR). Each marker can be assessed independently, but the markers collectively are typically associated together in systemic autoimmune disease and are, hence, described collectively here.
Secondary outcome
Change in point of care (at-home) blood ketones (beta-hydroxybutyrate)
Time frame: From baseline to the end of the study intervention at 24 weeks
Participants will collect periodic at-home measurements of blood ketones (beta-hydroxybutyrate) via a provided blood ketone meter. At-home blood ketones will be primarily utilized to assess adherence to prescribed dietary interventions or self implementation of a interventional dietary strategy for participants on the wait-list.
Secondary outcome
Change in point of care (at-home) blood glucose
Time frame: From baseline to the end of the study intervention at 24 weeks
Participants will collect periodic at-home measurements of blood glucose via a provided blood glucose meter. At-home blood glucose measurements will be primarily utilized to assess adherence and safety of the prescribed dietary regimens or self implementation of a interventional dietary strategy for participants on the wait-list.
Recruiting locations in the United States
Resilient Roots: Functional Medicine
RecruitingCharlottesville, Virginia, 22901, United States
Robert D Abbott, MD4342183425info@resilientrootsfxevomed.com
Emily Palmer, CNS4342183425info@resilientrootsfxevomed.com
Robert D Abbott, MD
Central study contacts
Registry dates
- First posted
- Apr 13, 2026
- Primary completion
- Sep 2027
- Overall completion
- Sep 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.